Postmarketing Drug Safety Compliance: 2019 Inspection Findings – Apr. 29, 2020 April 29, 2020

Webcast | Mixed

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• Date: April 29, 2020

FDA’s Postmarketing Adverse Drug Experience (PADE) Compliance Program monitors industry compliance with postmarketing laws and regulations for products regulated by the Center for Drug Evaluation and Research (CDER) to ensure that accurate, reliable, and timely safety data is submitted to FDA and available to reviewers who use this data to evaluate product safety.  This webinar provides an overview of the PADE Compliance Program, as well as discusses inspection findings and trends from PADE inspections completed in Fiscal Year 2019 (October 1, 2018 to September 30, 2019).

 

Slides

TOPICS COVERED

• Overview of FDA’s PADE Compliance Program
• Fiscal Year 2019 PADE Inspection Site Selection
• Fiscal Year 2019 PADE Inspection Findings

INTENDED AUDIENCE

• Regulatory affairs professionals working in pharmacovigilance
• Application holders for approved drugs and therapeutic biologics
• Manufacturers, packers, distributors, and retailers named on product labels of prescription and over-the-counter drugs and therapeutic biologics
• Contractors, vendors, and other third parties conducting pharmacovigilance activities
• Foreign regulators
• Healthcare professionals

LEARNING OBJECTIVES

• Identify the role of FDA’s Postmarketing Adverse Drug Experience (PADE) Compliance Program
• Describe recent PADE inspection findings and trends

FDA SPEAKER

Namita Kothary, PharmD, RAC (US)
Consumer Safety Officer
Division of Enforcement and Postmarketing Safety | Office of Scientific Investigations | Office of Compliance | CDER | FDA

FDA RESOURCES

• “Postmarketing Adverse Event Reporting Compliance Program”
• FDA Compliance Program “Postmarketing adverse drug experience reporting inspections”